NDA 21226, held by Abbvie. Lopinavir; Ritonavir.
As of Nov 14, 2026, NDA 21226 (Kaletra), held by Abbvie, was first approved by FDA on Sep 15, 2000, with 30 approved supplements and 0 published complete response letters.
| Jun 26, 2015 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Apr 20, 2007 | Supplement 18Efficacy (new indication or use) | Approved | |
| Apr 29, 2005 | Supplement 16Efficacy (new indication or use) | Approved | |
| Oct 19, 2004 | Supplement 14Efficacy (new indication or use) | Approved | |
| Nov 27, 2002 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2002 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jan 18, 2002 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 15, 2000 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kaletra133.3MG;33.3MG · capsule;oral | Lopinavir; Ritonavir | Discontinued |
| Oct 21, 2020 | Supplement 49Labeling · Standard review | Approved | |
| Dec 19, 2019 | Supplement 48Labeling · Standard review | Approved | |
| Aug 21, 2019 | Supplement 47Labeling · Standard review | Approved | |
| Nov 15, 2018 | Supplement 46Labeling · Standard review | Approved | |
| Jun 15, 2017 | Supplement 45Labeling · Standard review | Approved | |
| Nov 22, 2016 | Supplement 43Labeling · Standard review | Approved | |
| Sep 15, 2016 | Supplement 44Labeling | Approved | |
| Nov 10, 2015 | Supplement 42Labeling · Standard review | Approved | |
| Jun 26, 2015 | Supplement 40Efficacy (new indication or use) · Standard review | Approved | |
| Mar 27, 2015 | Supplement 41Labeling | Approved | |
| Nov 7, 2013 | Supplement 38Labeling · Standard review | Approved | |
| Jan 17, 2013 | Supplement 37Labeling · Standard review | Approved | |
| Jun 27, 2012 | Supplement 36Labeling · Standard review | Approved | |
| Feb 17, 2012 | Supplement 35Labeling | Approved | |
| Apr 27, 2010 | Supplement 30Labeling | Approved | |
| Sep 26, 2007 | Supplement 22Labeling · Standard review | Approved | |
| Jul 9, 2007 | Supplement 20Labeling · Standard review | Approved | |
| Apr 20, 2007 | Supplement 18Efficacy (new indication or use) | Approved | |
| Dec 21, 2006 | Supplement 19Labeling · Standard review | Approved | |
| Apr 29, 2005 | Supplement 16Efficacy (new indication or use) | Approved | |
| Mar 28, 2005 | Supplement 17Labeling · Standard review | Approved | |
| Oct 19, 2004 | Supplement 14Efficacy (new indication or use) | Approved | |
| Dec 3, 2003 | Supplement 12Labeling · Standard review | Approved | |
| Dec 24, 2002 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Nov 27, 2002 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Feb 13, 2002 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jan 18, 2002 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jan 18, 2002 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 13, 2001 | Supplement 2Labeling · Standard review | Approved | |
| Jan 30, 2001 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 15, 2000 | Original applicationNew molecular entity, new combination · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
